A Digital Self-Management Program (HOPE) for People Living with Cancer During the COVID-19 Pandemic: Findings from a Feasibility Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain Clark ◽  
Gabriela Matouskova ◽  
...  
Keyword(s):  
Intervention Group ◽  
Patient Activation ◽  
Management Program ◽  
Mental Wellbeing ◽  
Self Management ◽  
Control Group ◽  
Wait List Control ◽  
Definitive Trial ◽  
Secondary Outcomes

BACKGROUND Trial Design We present the results from a feasibility, randomised wait-list control group parallel design study, with a 1:1 allocation ratio. Participants were randomised to an intervention group or a waitlist control group.The intervention was a six-week digital self-management program (HOPE Program) for people with cancer. OBJECTIVE The aim of this study was to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive RCT. Additionally, preliminary assessment of the impact of the HOPE Program, via secondary outcomes, will be used to assess signals of efficacy in a trial context. METHODS Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support and were invited via email to take part in the study (N=61). Primary outcomes were rates of recruitment, retention, follow up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants’ positive mental wellbeing, depression, anxiety and patient activation (i.e. confidence to manage their cancer). The intervention and data collection took place online. RESULTS The recruitment rate was 77% (N=47). Forty one participants (n=41) completed the baseline questionnaires and were randomised to either the intervention group (n=21) or waitlist control group (n=20). The retention rate (attending all program sessions) was over 50% (all n=21, 51.2%; intervention group n=10, 47.6%; control group n=11, 55.0%), the follow up rate (completing all questionnaires) was over 80% (all 80.5%, n=33; intervention group 76.2%, n=16; control group 85.0%, n=17), and completion rate (attending 3 sessions and completing all questionnaires) was over 60% (all n=25, 61.0%; intervention group n=13, 61.9%; control group n=12, 60.0%). Engagement data showed that participants viewed between half (n=5.1, 51.0%) and three quarters (n=12.2, 76.3%) of the pages in each session. CONCLUSIONS All progression criteria for a definitive trial were met, as supported by the primary outcome data. On average, participants showed improved postprogram scores on measures of positive mental wellbeing, depression, anxiety and patient activation. A full scale trial of the digital HOPE Program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a control group. CLINICALTRIAL This feasibility randomised wait-list control trial was retrospectively registered with the ISRCTN registry (https://www.isrctn.com/ISRCTN79623250) on Nov 4, 2020. The feasibility trial protocol has been registered and published [International Registered Report Identifier (IRRID): DERR1-10.2196/24264. INTERNATIONAL REGISTERED REPORT RR2-10.2196/24264

scholarly journals Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023017 ◽  
Author(s):  
Torunn Hatlen Nøst ◽  
Aslak Steinsbekk ◽  
Ola Bratås ◽  
Kjersti Grønning
Keyword(s):  
Chronic Pain ◽  
Healthcare Service ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

Feasibility Study Of a Randomized Control Trial To Evaluate An Internet-Based Self-Management Program For Adolescents With Hemophilia

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2921-2921 ◽  
Author(s):  
Vicky R Breakey ◽  
Danial M Ignas ◽  
Ashley Warias ◽  
Meghan White ◽  
Victor S. Blanchette ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Randomized Control Trial ◽  
Intervention Group ◽  
Management Program ◽  
Attrition Rate ◽  
Self Management ◽  
Control Group ◽  
Randomized Control ◽  
Lost To Follow Up

Abstract Introduction As adolescents with hemophilia approach adulthood, they must assume responsibility for their health and management of their disease. An online self-management program was developed to support adolescents during this transition. Aim To determine the feasibility of studying the online educational program using a non-blind, randomized control trial(RCT) design in terms of 1)Study accrual and attrition rates, 2) willingness to be randomized 3) compliance with the program and completion of the outcome measures, and 4) satisfaction with the program. Methods Adolescents, ages 13-18, were enrolled from three tertiary care centres in Canada in a pilot RCT (NCT01477437). After providing informed consent, adolescents were randomized to the intervention (8 week program with telephone coaching) or the control arm (no access, weekly telephone call as attention-strategy). Adolescents in both arms of the study were asked to complete pre- and post- outcome measures. Following completion of the program, quantitative analysis addressed the feasilibity measures and qualitative interviews were conducted to assess satisfaction. Results 29 teens participated (intervention group, n=16, control group, n=13).Participants in the intervention arm spent an average of 50 minutes on the website per week completed the 8 modules in an average of 14 weeks (SD= 4.9). Among those randomized to the intervention, 2 participants dropped out of the study and 2 were lost to follow-up, resulting in an attrition rate of 25% (4/16). The control arm had a higher attrition rate of 54% (7/13) with 5 participants being lost to follow-up and 2 participants dropping out. For participants who completed the program, 17/18 (94%) completed the post-study outcome measures. Despite the study not being powered to assess efficacy, teens on the intervention arm showed significant improvement in disease-specific knowledge (p=0.004), self-efficacy (p=0.007) and transition preparedness (p=0.046) over time. There was a statistically significant improvement in the knowledge measure in the intervention group when compared to the control group (p=0.01). Overall, the teens found the website to be informative, comprehensive and easy to use and were satisfied with the program. Conclusions This feasibility study suggests benefit to the program and indicates a full scale RCT to be a reasonable next step with minor adjustments to the protocol. The higher than expected attrition rate in the control group, suggests the need to improve the strategies for maintaining participant engagement using a more active attention control group (static educational materials) in the design of this web-based intervention prior to a larger study to assess efficacy. Disclosures: Breakey: Baxter Bioscience: Research Funding.

Motivational Interviewing to Support Oral AntiCoagulation adherence in patients with non-valvular Atrial Fibrillation (MISOAC-AF): a randomised clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tzikas ◽  
A Samaras ◽  
A Kartas ◽  
D Vasdeki ◽  
G Fotos ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Medical Care ◽  
Oral Anticoagulation ◽  
Intervention Group ◽  
Control Group ◽  
Motivational Intervention ◽  
Clinical Events ◽  
Secondary Outcomes

Abstract Background Oral anticoagulation (OAC) is paramount to effective thromboprophylaxis; yet adherence to OAC remains largely suboptimal in patients with atrial fibrillation (AF). Purpose We aimed to assess the impact of an educational, motivational intervention on the adherence to OAC in patients with non-valvular AF. Methods Hospitalised patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence. The primary study outcome was adherence to OAC at 1-year, evaluated as Proportion of Days Covered (PDC) by OAC regimens and assessed through nationwide prescription registers. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, proportion of VKA-takers with labile INR (defined as time to therapeutic range<70%) and clinical events. Results A total of 1009 patients were randomised, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group had good adherence (PDC>80%), compared with 55% (280/509) in the control group (adjusted odds ratio 2.84, 95% confidence interval 2.14–3.75; p<0.001). Mean PDC±SD was 0.85±0.26 and 0.75±0.31, respectively (p<0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year, while usual medical care was associated with more major (≥3 months) treatment gaps [Figure]. Among 212 VKA-takers, patients in the intervention group were less likely to have labile INR compared with those in the control group [21/120 (17.1%) vs 34/92 (37.1%), OR 0.33 95% CI 1.15–0.72, p=0.005]. Clinical events over a median follow-up period of 2 years occurred at a numerically lower, yet non-significant, rate in the intervention group [Table]. Conclusions In patients receiving OAC therapy for non-valvular AF, a motivational intervention significantly improved patterns of medication adherence, without significantly affecting clinical outcomes. Primary and secondary outcomes Funding Acknowledgement Type of funding source: None

scholarly journals 83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Older People ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Medication Knowledge ◽  
Management Intervention ◽  
Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

Effects of a home-based physical training and activity promotion program in community-dwelling older persons with cognitive impairment after discharge from rehabilitation: A randomized controlled trial

2022 ◽  
Author(s):  
Phoebe Ullrich ◽  
Christian Werner ◽  
Anton Schönstein ◽  
Martin Bongartz ◽  
Tobias Eckert ◽  
...  
Keyword(s):  
Physical Training ◽  
Controlled Trial ◽  
Intervention Group ◽  
Physical Capacity ◽  
Control Group ◽  
Promotion Program ◽  
Home Based ◽  
Activity Promotion ◽  
Secondary Outcomes

Abstract Background Older people with cognitive impairment (CI) are at high risk for mobility limitations and adverse outcomes after discharge from geriatric rehabilitation settings. Study aim was to estimate the effects of a specifically designed home-based physical training and activity promotion program on physical capacity, different aspects of physical activity (PA), and psychosocial status. Methods Patients with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home after rehabilitation were included in this randomized, double-blind, placebo-controlled trial with a 12-week intervention and 12-week follow-up period. The intervention group performed a CI-specific, autonomous, home-based strength, balance and walking training supported by tailored motivational strategies to foster training adherence and promote PA. The control group participated in an unspecific motor placebo activity. Primary outcomes were physical capacity (Short Physical Performance Battery [SPPB]) and PA (sensor-based activity time). Results Among 118 randomized participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) and high levels of multi-morbidity, those participants undergoing home-based training demonstrated superior outcomes to the control group in SPPB (mean difference between groups 1.9 points; 95%-CI: 1.0-2.8; p<.001), with persistent benefits over the follow-up (1.3 points; 95%-CI: 0.4-2.2; p<.001). There were no differences in PA across any time points. Among secondary outcomes, fear of falling and activity avoidance behavior were reduced in the intervention group at all time points, life-space mobility improved short-term. Conclusions Study results demonstrate clinically important benefits of an individually tailored autonomous physical training and activity promotion program on physical capacity and secondary outcomes in different domains in a vulnerable, multi-morbid population.

scholarly journals Efficacy of a self-management program in patients with chronic viral hepatitis in China

BMC Nursing ◽  
2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Ying’ai Cui ◽  
Michiko Moriyama ◽  
Kazuaki Chayama ◽  
Yanhui Liu ◽  
Chunmei Ya ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Viral Hepatitis ◽  
Chronic Hepatitis B ◽  
Intervention Group ◽  
Chronic Viral Hepatitis ◽  
Management Program ◽  
Behavioral Changes ◽  
Self Management ◽  
Control Group

Abstract Background Chronic hepatitis, mainly B or C, increases the risk of hepatocellular carcinoma and remains an emerging issue in the globe. China has high rates of liver cancer incidence and mortality in the world. To address such challenges, adequate management of chronic hepatitis is required. Self-management education is one alternative for improving the hepatitis patients’ knowledge of the disease, mental health, and clinical management. This study aimed to examine the quality of life (QOL), psychological effects, and behavioral changes of a self-management program which allows continuity of care for chronic hepatitis B and C patients. Method In a six-month, randomized controlled trial, we invited 73 chronic hepatitis B/C inpatients to receive (i) two face-to-face education sessions provided by a nurse during hospitalization, and monthly telephone counseling at home after discharge; (ii) or usual care treatment (control group). The primary endpoint (patients’ QOL) and secondary outcomes (including self-efficacy, depression symptoms, perceived cognition of illness and behavioral changes) were assessed. In addition, we conducted qualitative data analysis to facilitate the evaluation of the interventions. Results Sixty (82.2%) out of 73 eligible patients with chronic hepatitis B/C (aged 34.9 ± 8.9 years) participated in the study. The intervention group (n = 30) significantly improved on outcomes including QOL, self-efficacy, perceived cognition of illness, and behavioral changes, whereas the control group significantly decreased their healthy behaviors. In terms of behavioral changes, alcohol avoidance, dietary adherence, and stress management also improved in the intervention group. However, there were no significant improvements in symptoms of depression. Most participants (80%) in the intervention group stated that they benefited from the program. Conclusions This program contributed to patients’ acquisition of self-management skills to cope with their illnesses, and significantly improved their QOL. This program serves as a reminder for nurses who care for patients with chronic viral hepatitis to acquire these skills as it would help them address the daily needs of their patients. Trial registration UMIN000025378. Registered December 23, 2016.

scholarly journals Effect of single follow-up home visit on readmission in a group of frail elderly patients – a Danish randomized clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Maurice A. Lembeck ◽  
Lau C. Thygesen ◽  
Birgitte Dreyer Sørensen ◽  
Lisbeth Lumby Rasmussen ◽  
Ellen A. Holm
Keyword(s):  
Elderly Patients ◽  
Functional Status ◽  
Frail Elderly ◽  
Home Visit ◽  
Hospital Admissions ◽  
Discharge Planning ◽  
Intervention Group ◽  
Control Group ◽  
Secondary Outcomes

Abstract Background Unplanned hospital admissions are costly and prevention of these has been a focus for research for decades. With this study we aimed to determine whether discharge planning including a single follow-up home visit reduces readmission rate. The intervention is not representing a new method but contributes to the evidence concerning intensity of the intervention in this patient group. Methods This study was a centrally randomized single-center controlled trial comparing intervention to usual care with investigator-blinded outcome assessment. Patients above the age of 65 were discharged from a single Danish hospital during 2013–2014 serving a rural and low socioeconomic area. For intervention patients study and department nurses reviewed discharge planning the day before discharge. On the day of discharge, study nurses accompanied the patient to their home, where they met with the municipal nurse. Together with the patient they reviewed cognitive skills, medicine, nutrition, mobility, functional status, and future appointments in the health care sector and intervened if appropriate. Readmission at any hospital in Denmark within 8, 30, and 180 days after discharge is reported. Secondary outcomes were time to first readmission, number of readmissions, length of stay, and readmission with Ambulatory Care Sensitive Conditions, visits to general practitioners, municipal services, and mortality. Results One thousand forty-nine patients aged > 65 years discharged from medical, geriatric, emergency, surgical or orthopedic departments met inclusion criteria characteristic of frailty, e.g. low functional status, need of more personal help and multiple medications. Among 945 eligible patients, 544 were randomized. Seven patients died before discharge. 56% in the intervention group and 54% in the control group were readmitted (p = 0.71) and 23% from the intervention group and 22% from the control group died within 180 days. There were no significant differences between intervention and control groups concerning other secondary outcomes. Conclusions There was no effect of a single follow-up home visit on readmission in a group of frail elderly patients discharged from hospital. Trial registration https://clinicaltrials.gov (identifier NCT02318680), retrospectively registered December 11, 2014.

Early rehabilitation after hospital admission for road trauma using an in-reach multidisciplinary team: a randomised controlled trial

2017 ◽  
Vol 31 (9) ◽  
pp. 1189-1200 ◽  
Author(s):  
Jane Wu ◽  
Steven G Faux ◽  
John Estell ◽  
Stephen Wilson ◽  
Ian Harris ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Usual Care ◽  
Intervention Group ◽  
Psychological Status ◽  
Randomised Control Trial ◽  
Control Group ◽  
Rehabilitation Team ◽  
Secondary Outcomes ◽  
The Impact

Objective: To investigate the impact of an in-reach rehabilitation team for patients admitted after road trauma. Design: Randomised control trial of usual care versus early involvement of in-reach rehabilitation team. Telephone follow-up was conducted by a blind assessor at three months for those with minor/moderate injuries and six months for serious/severe injuries. Setting: Four participating trauma services in New South Wales, Australia. Subjects: A total of 214 patients admitted during 2012-2015 with a length of stay of at least five days. Intervention: Provision of rehabilitation services in parallel with ward based therapy using an in-reach team for the intervention group. The control group could still access the ward based therapy (usual care). Main measures: The primary outcome was acute length of stay. Secondary outcomes included percentage requiring inpatient rehabilitation, function (Functional Independence Measure and Timed Up and Go Test), psychological status (Depression Anxiety and Stress Score 21), pain (Orebro Musculoskeletal Pain Questionnaire) and quality of life (Short Form-12 v2). Results: Median length of stay in acute care was 13 days (IQR 8-21). The intervention group, compared to the control group, received more physiotherapy and occupational therapy sessions (median number of sessions 16.0 versus 11.5, P=0.003). However, acute length of stay did not differ between the intervention and control groups (median 15 vs 12 days, P=0.37). There were no significant differences observed in the secondary outcomes at hospital discharge and follow-up. Conclusion: No additional benefit was found from the routine use of acute rehabilitation teams for trauma patients over and above usual care.

scholarly journals Efficacy of the Mindfulness Meditation Mobile App “Calm” to Reduce Stress Among College Students: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jennifer Huberty ◽  
Jeni Green ◽  
Christine Glissmann ◽  
Linda Larkey ◽  
Megan Puzia ◽  
...  
Keyword(s):  
College Students ◽  
Perceived Stress ◽  
Mindfulness Meditation ◽  
Intervention Group ◽  
Mobile App ◽  
Control Group ◽  
Wait List Control ◽  
Self Compassion ◽  
Mean Differences

BACKGROUND College students experience high levels of stress. Mindfulness meditation delivered via a mobile app may be an appealing, efficacious way to reduce stress in college students. OBJECTIVE We aimed to test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile app—Calm—compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention’s effect on health behaviors (ie, sleep disturbance, alcohol consumption [binge drinking], physical activity, and healthy eating [fruit and vegetable consumption]) and the feasibility and acceptability of the app. METHODS This study was a randomized, wait-list, control trial with assessments at baseline, postintervention (8 weeks), and at follow-up (12 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored ≥14 points on the Perceived Stress Scale, (3) owned a smartphone, (4) were willing to download the Calm app, (5) were willing to be randomized, and (7) were able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A P value ≤.05 was considered statistically significant. RESULTS A total of 88 participants were included in the analysis. The mean age (SD) was 20.41 (2.31) years for the intervention group and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between the intervention and control groups after adjustment for covariates postintervention (all P<.04). These effects persisted at follow-up (all P<.03), except for the nonreacting subscale of mindfulness (P=.08). There was a significant interaction between group and time factors in perceived stress (P=.002), mindfulness (P<.001), and self-compassion (P<.001). Bonferroni posthoc tests showed significant within-group mean differences for perceived stress in the intervention group (P<.001), while there were no significant within-group mean differences in the control group (all P>.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group×time interaction in models of sleep disturbance was found, but no significant effects were found for other health behaviors. The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future. The majority were satisfied using Calm and likely to recommend it to other college students. The intervention group participated in meditation for an average of 38 minutes/week during the intervention and 20 minutes/week during follow-up. CONCLUSIONS Calm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college students. Our findings provide important information that can be applied to the design of future studies or mental health resources in university programs. CLINICALTRIAL ClinicalTrials.gov NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810

P573Effects of mobile text messaging on glycemic control in patients with coronary heart disease and diabetes mellitus: a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
X H Huo ◽  
H M K Krumholz ◽  
X B Bai ◽  
E S S Spatz ◽  
Q D Ding ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Coronary Heart Disease ◽  
Text Messaging ◽  
Hba1c Level ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Secondary Outcomes

Abstract Background Mobile health interventions hold the prospect to support risk factor and lifestyle modification and are readily scalable in healthcare systems. Purpose We aim to assess whether text messaging program can improve glycemic control in high-risk patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods The study was a multi-centre randomised clinical trial conducted at 34 clinics in China. 502 individuals with both CHD and DM were recruited and randomly assigned to either the text messaging intervention (n=251) or control group (n=251). The control group received 2 thank-you messages per month in addition to usual care. The intervention group received 6 messages per week for 6 months. Messages provided educational and motivational information related to glucose monitoring, BP control, physical activity and lifestyle recommendations. The primary outcome was change in glycemic hemoglobin (HbA1C) from baseline to 6 months. Results Follow-up rate was 99%. At 6 months, HbA1C was significantly lower in intervention group compared to control group (mean HbA1C 6.7% vs. 7.2%, P<0.001), with a mean change of −0.2% and 0.1% from baseline, respectively (mean absolute change −0.3% [95% CI −0.5 to 0.1]; P=0.003). Significantly more participants in intervention group achieved a HbA1c<7% (69.3% vs. 52.6%; P=0.004), and change in FBG was larger in intervention group (−0.5 vs. 0.1 mmol/L; P=0.011). No differences in SBP, LDL-C, BMI and physical activity were observed. Almost all patients reported messages to be easy to understand (97.1%) and useful (94.1%). Table 1. Primary and Secondary Outcomes Analyses at 6 Month Follow-up Parameter Intervention (N=251) Control (N=251) Mean Difference in Change P value for Baseline 6 Months Mean Change Baseline 6 Months Mean Change (95% CI) Difference in Change Primary Outcome HbA1C level, %, mean (SD) 6.9 (1.4) 6.7 (1.3) −0.2 (1.0) 7.1 (1.4) 7.2 (1.5) 0.1 (1.1) −0.3 (−0.5, −0.1) 0.003 Secondary Outcomes HbA1C level<7%, No. (%) 155 (62.0%) 174 (69.3%) – 139 (56.1%) 132 (52.6%) – 1.2 (1.1, 1.3)a 0.004   FBG, mmol/L, mean (SD) 8.1 (2.7) 7.5 (2.7) −0.5 (2.5) 8.5 (3.0) 8.6 (3.3) 0.1 (3.1) −0.6 (−1.1, −0.2) 0.011   SBP, mmHg, mean (SD) 135.9 (18.4) 134.7 (18.7) −1.4 (17.1) 135.9 (18.1) 132.2 (17.7) −3.5 (17.8) 2.4 (−0.8,5.5) 0.144   LDL-C, mmol/L, mean (SD) 2.6 (0.8) 2.5 (0.7) −0.1 (0.7) 2.6 (0.8) 2.5 (0.8) −0.1 (0.7) 0 (−0.1, 0.1) 0.828   BMI, mean (SD) 26.4 (3.2) 26.3 (3.5) −0.1 (2.1) 26.3 (3.2) 26.0 (3.4) −0.4 (2.5) 0.3 (−0.1, 0.7) 0.213   Physical activity (MET min/wk), 1386 1386 177 1386 1386 322 −70.7 0.784     median (IQR) (693–3066) (918–3612) (2840) (693–3066) (693–3002) (2635) (−574.9, 433.5) Conclusion Use of a simple, culturally sensitive mobile text-messaging program could be an effective and scalable way to improve disease self-management among patients with CHD and DM. Acknowledgement/Funding Research Special Fund for Public Welfare Industry of Health (201502009) from the National Health and Family Planning Commission of China

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